# K223218: Parietene Macroporous Mesh

- Pathway: 510(k) (Special)
- Applicant: Sofradim Production
- Decided: Dec 2, 2022 after 46 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K991400 (1999). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142091: Parietene Macroporous Mesh, Sofradim Production (2014) Summary page 4.

## Most influential descendants
- K250869: Parietene™ Macroporous Mesh  (PPM5050 ) (2025), 0 descendants of its own

## Indications for use
Parietene™ macroporous mesh is intended for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.

Source page: https://510kreport.com/device/K223218
Methodology: https://510kreport.com/methodology